Objective

To provide guidance on emerging good practices for surrogacy evaluation and validation of the relationship between outcomes quantitatively informing HTA. The report will outline different methods to deal with the use of surrogate evidence and how to make appropriate decisions when the relationship between outcomes and their associated treatment effects are used.

Rationale

The task force addresses a gap in guidance in an increasingly important area. This task force will discuss how data can qualitatively and quantitatively be used for HTA purposes to obtain evidence of implicitly or explicitly used relationships, where in some situations sufficient evidence is collected and in other situations only supportive evidence is obtained. Although surrogacy is only one element of multi-dimensional decision-making, creating principles for establishing and understanding surrogacy can help reduce variability in this aspect of decision-making.

Co-Chairs:

Sylwia Bujkiewicz, MSc, PhD

Professor of Biostatistics, University of Leicester
Leicester, United Kingdom

Oriana Ciani, MSc, PhD, BSc

Associate Professor of Practice, Center for Research on Health and Social Care Management, SDA Bocconi
Milan, MI, Italy

Bart Heeg, PhD

Vice President, Cytel
Rotterdam, ZH, Netherlands

Mario Ouwens, MSc, PhD

Group Director, Medical and Payer Evidence Statistics, Astrazeneca
Mölndal, O, Sweden

Leadership Group

Marc Buyse

Chief Scientific Officer, IDDI
Louvain-la-Neuve, WBR, Belgium

Wanrudee Isaranuwatchai, PhD, BSc

Director, Health Intervention and Technology Assessment Program (HITAP), Ministry of Public Health Thailand
Toronto, ON, Canada

Jeanette Kusel, MSc, BA

Director NICE Scientific Advice, NICE
London, United Kingdom

Dawn Lee, MSc

Associate Professor, University of Exeter Medical School
Exeter, DEV, United Kingdom

Dr. rer. nat. Jona Lilienthal

Staff Member, Dept of Medical Biometry, IQWiG
Cologne, NW, Germany

Petros Pechlivanoglou, MSc, PhD, BSc

Senior Scientist, Child Health Evaluative Sciences, The Hospital for Sick Children
Toronto, ON, Canada

Stephen Stefani, PhD, MD

President, ISPOR Brasil Chapter
Porto Alegre, RS, Brazil

Kristian Thorlund, MSc, PhD

Part-time Professor, McMaster University
Hamilton, ON, Canada

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